- FDA investigating allergic reactions to Pfizer vaccine reported in multiple states (thehill.com)Vaccinations at Chicago-area hospital to resume after 4 workers experience adverse reactions (fox32chicago.com)
The Food and Drug Administration is investigating allergic reactions to the Pfizer coronavirus vaccine that were reported in multiple states after it began to be administered this week...Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters late Friday that the reactions had been reported in more than one state besides Alaska and that the FDA is probing five reactions...“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said...READ MORE
- Historic U.S. vaccine campaign begins with first shipments ‘delivering hope’ to millions (reuters.com)U.S. expects to have immunized 100 million against COVID-19 by end of March -Slaoui (reuters.com)U.S. CDC director 'proud' to sign advisory panel recommendation of COVID vaccine (reuters.com)White House, other top officials to get early vaccine access (apnews.com)
The first shipments of COVID-19 vaccine left on trucks and planes early on Sunday, kicking off a historic effort to stop a surging pandemic that is claiming more than 2,400 lives a day in the United States...Mask-wearing workers at a Pfizer Inc factory in Michigan began packing the first shipments of the vaccine developed with German partner BioNTech SE in dry ice shortly after 6:30 a.m. ET (1130 GMT) on Sunday...Trucks carrying pallets of boxed, refrigerated vaccine began rolling away from the Kalamazoo facility, escorted by body armor-clad security officers. The shots then were loaded onto FedEx and United Parcel Service planes that will whisk the precious cargo across the country...“Today, we’re not hauling freight, we’re delivering hope,”...READ MORE
- Signed, sealed, delivered: Pfizer marks first ‘mass air shipment’ of COVID-19 shot amid cold-chain scrutiny (fiercepharma.com)
Pfizer, alone among its peers, has faced fever-pitch scrutiny over the stringent cold storage requirements for its COVID-19 vaccine—and the logistical challenges that could pose. Looking to ease the doubters' concerns, Pfizer has now shipped its first doses by air to the U.S., and distributors are watching closely...Late last week, United Airlines started ferrying Pfizer’s COVID-19 vaccine hopeful from the Brussels International Airport in Belgium to Chicago O'Hare...marking the first “mass air shipment” of a coronavirus vaccine...READ MORE
- Baxter’s CDMO arm will add 100 new positions in $50M fill-finish expansion of Indiana plant (fiercepharma.com)
...the contract manufacturing market has seen a wave of investment in the U.S. amid the COVID-19 pandemic and a call for "onshore" drug production...Baxter Biopharma Solutions, the CDMO arm of healthcare giant Baxter, will shell out $50 million in an expansion to its fill-finish manufacturing plant in Bloomington, Indiana, that will eventually bring 100 new positions on board...The expansion will add a 25,000-square-foot warehouse; a new filling line for flexible plastic containers; a high-speed automated syringe fill line capable of filling up to 600 units per minute; and a new high-speed, automated visual inspection line...READ MORE
- Las Vegas hospital administers Nevada’s first batch of COVID vaccines (thenevadaindependent.com)
University Medical Center became the first hospital in Nevada to administer the COVID-19 vaccine on Monday, marking a major turning point...UMC began administering the vaccine at 11:45 a.m., and by 4 p.m., the hospital had vaccinated more than 200 frontline health care workers in line with guidance from the Centers for Disease Control and Prevention and the state, said UMC CEO Mason Van Houweling...ICU nurse Roshele Ward was the first UMC employee — and the first Nevadan — to be vaccinated...READ MORE
- U.K. Regulator Warns People With ‘Significant’ Allergies To Avoid Pfizer-BioNTech Vaccine (forbes.com)Explainer: What do the UK allergic reaction cases mean for Pfizer's COVID-19 vaccine (reuters.com)FDA staffers sing Pfizer/BioNTech COVID-19 shot's praises ahead of key committee meeting (fiercepharma.com)
One day after the U.K was hailed for administering the first coronavirus vaccine shots in the west, Britain’s medicines regulator has warned people with a history of “significant” allergies to avoid the Pfizer-BioNTech Covid-19 vaccine...Two National Health Service staff members experienced anaphylactoid reactions after receiving the...vaccine on the first day of the U.K.’s vaccination campaign...READ MORE
- Analysis: Questions over AstraZeneca’s COVID-19 vaccine data risk delaying approval (reuters.com)The AstraZeneca Covid Vaccine Data Isn't Up to Snuff (wired.com)
Days after grabbing headlines with its COVID-19 “vaccine for the world”, AstraZeneca is facing tricky questions about its success rate that some experts say could hinder its chances of getting speedy U.S. and EU regulatory approval...Several scientists have raised doubts about the robustness of results showing the shot was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose...“All we have to go on is a limited data release,” said Peter Openshaw, a professor of experimental medicine at Imperial College London. “We have to wait for the full data and to see how the regulators view the results,” he said, adding that U.S. and European regulators “might possibly take a different view” from each other...READ MORE
- Canada getting 168K Moderna vaccine doses before year end (apnews.com)
Prime Minister Justin Trudeau said Tuesday that Canada has contracted to receive up to 168,000 doses of the Moderna COVID-19 vaccine before the end of December, pending approval by the country’s health regulator...Canadians began receiving vaccine shots developed by Pfizer and BioNTech on Monday and Trudeau said Canada expects to receive about 200,000 doses from Pfizer next week. Canada received an initial batch of 30,000 this week...READ MORE
- Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles (wsj.com)
Pharma giant expects to ship half the doses it had originally planned after finding raw materials in early production didn’t meet its standards...When Pfizer Inc. said last month it expects to ship half the Covid-19 vaccines it had originally planned for this year, the decision highlighted the challenges drug makers face in rapidly building supply chains to meet the high demand...“Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”...READ MORE
- Roche’s Genentech cleared for massive headquarters expansion that will add up to 4.3M square feet (fiercepharma.com)
More than 40 years since setting up shop in a rented warehouse as the modern world’s first biotech company, Roche’s Genentech is now up for a major expansion at its South San Francisco home in California...the local city council approved Genentech’s expansion proposal, which aims to almost double its headquarters’ building space to 9 million square feet from the current 4.7 million square feet...That extra buildout, all within the boundary of its existing 207-acre campus, allows the Roche unit to add as many as 12,550 employees at the HQ on top of the 10,000 or so who are there right now, according to the master plan...READ MORE